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Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers


N/A
20 Years
60 Years
Open (Enrolling)
Male
Obesity, Prostate Cancer

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Trial Information

Effect of Lap-Band Induced Weight Loss on Serum PSA Levels, Testosterone, Estrogen and Other Serum Markers


The main objective of this study is to determine whether interpretation of PSA levels in
morbidly obese men require correction due to the obesity itself. Secondary outcome measures
that will be followed include the affect of obesity and weight loss on testosterone,
estradiol and leptin. In as much as these might also affect PSA, we will be measuring these
values as well. Also, we do not know the effects of lap-band induced weight loss on
clinical outcome measures of sexual, bowel and urinary function. Thus we will aim to
investigate these parameters as well.


Inclusion Criteria:



- obese men undergoing lap-band surgey

Exclusion Criteria:

- prior diagnosis of prostate cancer, prior prostate surgery, use of 5-alpha reductase
inhibitors and history prostatitsis or recurrent UTI.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

PSA value

Outcome Time Frame:

18 months

Principal Investigator

Jason Wynberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MMC

Authority:

United States: Institutional Review Board

Study ID:

07/09/VA18

NCT ID:

NCT00562341

Start Date:

November 2007

Completion Date:

December 2009

Related Keywords:

  • Obesity
  • Prostate Cancer
  • obesity
  • psa
  • prostate cancer
  • Obesity
  • Prostatic Neoplasms
  • Weight Loss

Name

Location

Maimonides Medical CenterBrooklyn, New York  11219